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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K212930
Device Name LumiVy Lumbar IBF System
Applicant
Vy Spine, LLC
2236 Capital Circle NE, Suite 103-1
Tallahassee,  FL  32308
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
2236 Capital Circle NE, Suite 103-1
Tallahassee,  FL  32308
Correspondent Contact Jordan Hendrickson
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/14/2021
Decision Date 02/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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